NCT00427856

A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)

Completed Phase 2 Last updated 20 July 2016

What this trial tests

Phase 2 trial testing Obatoclax mesylate in Lymphoma, Follicular in 7 participants. Completed in 1 July 2009.

Timeline

1 March 2007

Primary endpoint
1 February 2009

1 July 2009

Quick facts

Lead sponsor	Gemin X
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 March 2007
Primary completion	1 February 2009
Estimated completion	1 July 2009
Sites	1 location across United States

Drugs / interventions tested

• Obatoclax mesylate — full drug profile →
• Rituximab — full drug profile →

Conditions studied

• Lymphoma, Follicular — all drugs for Lymphoma, Follicular →

Sponsor

Gemin X — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Follicular. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response rate
  Time frame: 12 weeks

Sponsor's own description

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the Bcl-2 Family in B Cell Lymphoma.
   Adams CM, Clark-Garvey S, Porcu P, Eischen CM. · · 2018 · cited 112× · PMID 30671383 · DOI 10.3389/fonc.2018.00636
2. Ionophores: Potential Use as Anticancer Drugs and Chemosensitizers.
   Kaushik V, Yakisich JS, Kumar A, Azad N, et al · · 2018 · cited 58× · PMID 30262730 · DOI 10.3390/cancers10100360
3. Novel Drugs in Follicular Lymphoma.
   Anastasia A, Rossi G. · · 2016 · cited 9× · PMID 27872741 · DOI 10.4084/mjhid.2016.061
4. Pharmaceutical Agents for Targeting Autophagy and Their Applications in Clinics.
   Kench U, Sologova S, Smolyarchuk E, Prassolov V, et al · · 2024 · cited 6× · PMID 39458996 · DOI 10.3390/ph17101355
5. BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.
   Silva JPN, Pinto B, Silva PMA, Bousbaa H. · · 2026 · cited 1× · PMID 41596764 · DOI 10.3390/ijms27021123
6. Targeting autophagy in dysfunctional tumor vasculature.
   Lin Q, Cai B, Ke R, Ni X, et al · · 2025 · PMID 41431685 · DOI 10.1016/j.isci.2025.114084